Phase 2
Completed N=229
Arasertaconazole Nitrate Pessaries - Dose Finding Study for the Vulvovaginal Candidiasis (VVC) Treatment
Source: ClinicalTrials.gov NCT01144286 ↗Enrolled (actual)
229
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Dose-response of Clinical and Mycological (Global) Therapeutic Response — 31.7; 48.7; 47.6; 53.8 percentage of patients cured — p=0.0630
Summary
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 mg, 300 mg or 600 mg, pessaries).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose-response of Clinical and Mycological (Global) Therapeutic Response |
31.7; 48.7; 47.6; 53.8 | 0.0630 |
| SECONDARY Dose-response of Clinical and Mycological (Global)Therapeutic Response |
15.6; 34.2; 46.3; 61.0 | — |
Eligibility Criteria
Inclusion Criteria
- Women aged between 18 to 65 years of age who have signed the informed consent.
- Not pregnant, not nursing.
- No indication of other vulvovaginitis or genital infections
- Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
- Negative wet mount results for T. vaginalis and clue cells.
- Exclusion Criteria:
- Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
- Hypersensitivity to imidazole products administered topically.
- Any other medical condition which in the opinion of the investigator could interfere with study conduct.
Data sourced from ClinicalTrials.gov (NCT01144286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.